- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00226980
A Trial of Thalidomide and Capecitabine in Metastatic Renal Cell Carcinoma
April 10, 2009 updated by: Stanford University
A Phase II Trial of Thalidomide and Capecitabine in Metastatic Renal Cell Carcinoma
The purpose of this study is to determine the efficacy of the combination of thalidomide and capecitabine in metastatic renal cell carcinoma and also to determine the safety of the combination.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
30
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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California
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Stanford, California, United States, 94305
- Stanford University School of Medicine
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:- Able to comprehend and sign an IRB approved Informed consent
- Willingness and ability to comply with the FDA-mandated S.T.E.P.S.® program.
- Male or female 18 years or older
- Willing to use contraception
- Pathologic diagnosis of renal cell carcinoma
- Bi-dimensionally measurable disease
- Evidence of disease progression prior to start of treatment
- Failed prior immunotherapy or unwilling/unable to receive prior immunotherapy
- Adequate hematologic data: ANC.1.5; platelets>100x10^9
- Adequate renal function: Creatinine clearance .50cc
- Adequate liver function: Alkaline phos <3XULN AST/ALT <3XULN T.Bili <1.5XULN
- ECOG performance status 0-1 Exclusion Criteria:- Known brain metastases.
- Peripheral neuropathy.
- Pregnant and/ or lactating female.
- Unable to take a baby aspirin.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Efficacy of the combination of thalidomide and capecitabine in metastatic renal cell carcinoma.
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Secondary Outcome Measures
Outcome Measure |
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Safety of the combination
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2002
Primary Completion (Actual)
July 1, 2005
Study Completion (Actual)
July 1, 2006
Study Registration Dates
First Submitted
September 13, 2005
First Submitted That Met QC Criteria
September 23, 2005
First Posted (Estimate)
September 27, 2005
Study Record Updates
Last Update Posted (Estimate)
April 14, 2009
Last Update Submitted That Met QC Criteria
April 10, 2009
Last Verified
April 1, 2009
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Urologic Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Kidney Diseases
- Urologic Diseases
- Adenocarcinoma
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Kidney Neoplasms
- Carcinoma, Renal Cell
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Angiogenesis Inhibitors
- Angiogenesis Modulating Agents
- Growth Substances
- Growth Inhibitors
- Anti-Bacterial Agents
- Leprostatic Agents
- Thalidomide
- Capecitabine
Other Study ID Numbers
- RENAL0001
- NCT00226980
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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